Medpace
Study Start-Up Project Manager - Cell and Gene Based Therapy
Medpace, Denver, Colorado, United States, 80285
Study Start-Up Project Manager - Cell and Gene Based TherapyJob Locations:
United States-OH-Cincinnati | United States-CO-Denver | United States-TX-Irving (Dallas)
Category:
Site Activation & Maintenance
Job SummaryDo you enjoy working in a fast-paced environment where you are empowered to make strategic decisions and contribute to a growing and profitable company? Join us at Medpace! Our clinical operations activities are growing rapidly, and we are currently seeking a full-time,
Global Study Start-Up Project Manager
to join our Clinical Operations team. This position plays a key role in the clinical trial management process at Medpace.
Incentives can include:
Competitive bonus program, sign-on/relocation bonus, and equity awards.
Location:
Position can be office based in Cincinnati, Dallas or Denver.
Responsibilities
Efficiently manage successful execution of global start-up, maintenance, and close-out;
Effectively lead others in a matrix environment;
Perform quality checks on submission documents and site essential documents;
Prepare and approve informed consent forms;
Serve as a Sponsor point of contact for start-up and regulatory submissions items;
Review pertinent regulations to develop proactive solutions to start-up challenges;
Prepare new business proposals and present during bid defenses, general capabilities meetings, and audits;
Contribute to the growth and development of departmental staff, processes, and systems.
Qualifications
Bachelor's degree required, advanced degree in Life Sciences preferred
5+ years of experience in clinical research, preferably in a Senior/Lead role at a CRO in Study Start-Up
Experience in the use of cell- and gene-based therapy for clinical trials
Project management experience and demonstrated role in developing others
Strong oral and written communication skills required
Travel:
Minimal
Medpace OverviewMedpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Cincinnati Perks
Cincinnati Campus Overview
Hybrid work-from-home options (dependent upon position and level)
Competitive PTO packages, starting at 20+ days
Competitive compensation and benefits package
Flexible work schedule
Company-sponsored employee appreciation events
Employee health and wellness initiatives
Community involvement with local nonprofit organizations
Discounts on local sports games, fitness gyms and attractions
Modern, ecofriendly campus with an on-site fitness center
Structured career paths with opportunities for professional growth
Discounted tuition for UC online programs
Awards
Named a Top Workplace in 2024 by The Cincinnati Enquirer
Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect NextA Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
EO/AA Employer M/F/Disability/Vets
#J-18808-Ljbffr
United States-OH-Cincinnati | United States-CO-Denver | United States-TX-Irving (Dallas)
Category:
Site Activation & Maintenance
Job SummaryDo you enjoy working in a fast-paced environment where you are empowered to make strategic decisions and contribute to a growing and profitable company? Join us at Medpace! Our clinical operations activities are growing rapidly, and we are currently seeking a full-time,
Global Study Start-Up Project Manager
to join our Clinical Operations team. This position plays a key role in the clinical trial management process at Medpace.
Incentives can include:
Competitive bonus program, sign-on/relocation bonus, and equity awards.
Location:
Position can be office based in Cincinnati, Dallas or Denver.
Responsibilities
Efficiently manage successful execution of global start-up, maintenance, and close-out;
Effectively lead others in a matrix environment;
Perform quality checks on submission documents and site essential documents;
Prepare and approve informed consent forms;
Serve as a Sponsor point of contact for start-up and regulatory submissions items;
Review pertinent regulations to develop proactive solutions to start-up challenges;
Prepare new business proposals and present during bid defenses, general capabilities meetings, and audits;
Contribute to the growth and development of departmental staff, processes, and systems.
Qualifications
Bachelor's degree required, advanced degree in Life Sciences preferred
5+ years of experience in clinical research, preferably in a Senior/Lead role at a CRO in Study Start-Up
Experience in the use of cell- and gene-based therapy for clinical trials
Project management experience and demonstrated role in developing others
Strong oral and written communication skills required
Travel:
Minimal
Medpace OverviewMedpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Cincinnati Perks
Cincinnati Campus Overview
Hybrid work-from-home options (dependent upon position and level)
Competitive PTO packages, starting at 20+ days
Competitive compensation and benefits package
Flexible work schedule
Company-sponsored employee appreciation events
Employee health and wellness initiatives
Community involvement with local nonprofit organizations
Discounts on local sports games, fitness gyms and attractions
Modern, ecofriendly campus with an on-site fitness center
Structured career paths with opportunities for professional growth
Discounted tuition for UC online programs
Awards
Named a Top Workplace in 2024 by The Cincinnati Enquirer
Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect NextA Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
EO/AA Employer M/F/Disability/Vets
#J-18808-Ljbffr